Cook Medical are currently seeking an experienced Product Development Engineer to join their team.
Design, development and taking to market of medical devices for one or more Cook Medical Strategic Business Units.
- Perform Duties of Research & Development Engineer:
- Design development, prototyping, test method design, design evaluation, design reviews, design specifications, design verification and validation, design protocols and reports, transfer to production activities in a timely effective manner.
- Product testing and evaluation, completion of test reports to support design selection
- Preparation and presentation of design reviews
- Product and project risk analysis and risk management.
- Work with Manufacturing Engineering to introduce new equipment and production processes as required for any new manufacturing techniques.
- Source new materials components and equipment.
- Development of component specifications, inspection methods, bills of materials and manufacturing processes.
- Introduction of new equipment, materials and technologies.
- Work closely with Key Opinion Leaders (KOL’s), physicians and product managers to develop innovative medical devices to improve patient care.
- Project lead for assigned product development projects including technical and project management responsibly.
- Manage and drive project tasks to ensure timely completion of project milestones.
- Work closely with cross functional groups to achieve project and company goals.
- Product performance evaluations.
- Contribute to innovation and creativity within team through filing of disclosures and patents.
- Hold regular project meetings and document minutes and actions.
- Ensure project milestones are achieved to meet business metrics
- Compliance with Quality, Regulatory and company policies and systems.
- Regular communication to cross-functional teams, senior management and business unit leaders.
- Project status communications and reporting.
- Remain on the forefront of emerging industry practices.
- Educating oneself in the medical area for which the new devices are being developed in order to have an appreciation for what needs to be achieved with these products.
- Support other cross functional groups to deliver company goals.
- Ensure that Cook’s Code of Conduct is complied with in all business matters carried out on Cook’s behalf.
- Third level degree in Mechanical, Biomedical, Design, Chemical Engineering or similar discipline.
- 2 Years design experience medical device roles.
- Project planning skills.
- Execution of project in a timely effective manner
- Knowledge of anatomy and physiology.
- Good mechanical design and understanding of engineering fundamentals with extensive medical device materials knowledge.
- Manufacturing design and process understanding
- Good working knowledge of Solidworks and/or Pro Engineer CAD.
- Strong technical writer.
- Knowledge of medical device quality & regulatory systems and medical device directives (ISO13485 and FDA CFR 820)
- Team Player with ability to develop strong working relationships.
- Strong communication and inter-personal skills.
- Good problem solving skills.
- Highly motivated individual, self starter with a passion for excellence.
- Must be able to work in a fast paced environment.